MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 23 G X .75 IN. BD VACUTAINER® WINGED SAFETY PUSH BUTTON BLOOD COLLECTION SET

Catalog Number 367324

Device Problem Shielding Failure (1568)

Patient Problem Needle Stick/Puncture (2462)

Event Date 10/14/2016

Event Type  malfunction  

Manufacturer Narrative

A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.Udi #: (b)(4).

Event Description

It was reported that a 23 g x.75 in.Bd vacutainer® winged safety push button blood collection set with 12 in.Tubing was without its protective shield.An employee was stuck with a clean needle before patient use.There was no report of medical intervention.

Manufacturer Narrative

Results: unused and sealed samples were returned for evaluation.A 100% visual/microscopic inspection revealed no defects for missing protector, foreign matter, bevel orientation, or needle point damage.All units received met manufacturing specifications.A review of the device history record and quality notifications revealed no irregularities during the manufacture of the reported lot # 6148626.Conclusion: an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.

• Brand Name: 23 G X .75 IN. BD VACUTAINER® WINGED SAFETY PUSH BUTTON BLOOD COLLECTION SET
• Type of Device: BLOOD COLLECTION SET
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6077436
• MDR Text Key: 59501512
• Report Number: 1710034-2016-00049
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Phlebotomist
• Type of Report: Initial,Followup
• Report Date: 12/08/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 367324
• Device Lot Number: 6148626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other